Frobengolmed

Package leaflet: Information for the user

FROBENGOLMED 8.75 mg/dose oral mucosa spray, solution

flurbiprofen
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

1. What FROBENGOLMED is and what it is used for
2. What you need to know before using FROBENGOLMED
3. How to use FROBENGOLMED
4. Possible side effects
5. How to store FROBENGOLMED
6. Contents of the pack and other information

1. What FROBENGOLMED is and what it is used for

FROBENGOLMED contains the active substance flurbiprofen. Flurbiprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by modifying the body's response to pain, swelling, and fever.
FROBENGOLMED is indicated for the relief of sore throat symptoms such as throat inflammation, pain, difficulty in swallowing, and swelling, for short-term treatment in adults aged 18 years and over.

2. What you need to know before using FROBENGOLMED

Do not take FROBENGOLMED if:

• you are allergic to flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or to any of the other ingredients listed in section 6.
• you have previously experienced allergic reactions after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); for example, asthma, wheezing, itching, runny nose, skin rashes, or swelling.
• you have or have had one or more episodes of stomach ulcer or bleeding, or intestinal ulcer.
• you have had severe colitis (inflammation of the intestine).
• you have experienced blood clotting or bleeding problems after taking NSAIDs.
• you are in the last three months of pregnancy.
• you suffer from severe heart failure, severe renal failure, or severe hepatic failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking FROBENGOLMED if:

• you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin.
• you have tonsillitis (inflamed tonsils) or suspect you have a bacterial throat infection (since antibiotics may be needed).
• you have an infection – refer to the section "Infections" below.
• you are elderly (as you are more likely to experience adverse effects).
• you have or have had asthma or suffer from allergies.
• you suffer from a skin condition known as systemic lupus erythematosus or mixed connective tissue disease.
• you have hypertension (high blood pressure).
• you have a history of intestinal disorders (ulcerative colitis, Crohn's disease).
• you have heart, kidney, or liver problems.
• you have had a stroke.
• you are in the first 6 months of pregnancy or are breastfeeding.

While using FROBENGOLMED

• At the first sign of any skin reaction (rash, peeling, blistering rash) or other symptoms of an allergic reaction, stop using the spray immediately and consult a doctor promptly.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding).
• Consult your doctor if you do not notice improvement, if your condition worsens, or if you develop new symptoms.
• Medicines such as flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay appropriate treatment of the infection, which in turn may increase the risk of complications. If you take this medicine during an infection and symptoms of infection persist or worsen, contact your doctor or pharmacist immediately.

Children
This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and FROBENGOLMED
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription. In particular:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of stomach or intestinal bleeding
• warfarin, aspirin (acetylsalicylic acid), and other anticoagulant or blood-thinning medicines
• ACE inhibitors, angiotensin II antagonists (antihypertensive medicines)
• diuretics (medicines that increase urine production), including potassium-sparing diuretics
• SSRIs (selective serotonin reuptake inhibitors) for depression
• cardiac glycosides such as digoxin (for heart problems)
• cyclosporine (to prevent organ transplant rejection)
• corticosteroids (to reduce inflammation)
• lithium (for behavioral disorders)
• methotrexate (for psoriasis, arthritis, and cancer)
• mifepristone (used to terminate a pregnancy); NSAIDs must not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness
• oral antidiabetic medicines
• phenytoin (for epilepsy)
• probenecid, sulfinpyrazone (for gout and arthritis)
• quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin
• tacrolimus (an immunosuppressant used after organ transplantation)
• zidovudine (for HIV)

FROBENGOLMED with food, drinks, and alcohol
Alcohol intake should be avoided during treatment with this medicine, as it may increase the risk of stomach and intestinal bleeding.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn. It is not known whether the same risk applies to Frobengolmed 8.75 mg/dose oral mucosa spray, solution.
Do not take Frobengolmed 8.75 mg/dose oral mucosa spray, solution during the last three months of pregnancy. Do not take Frobengolmed 8.75 mg/dose oral mucosa spray, solution during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period, you should take the lowest possible dose for the shortest possible time.

Breastfeeding
Do not use this medicine if you are breastfeeding.

Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible when treatment is stopped. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have fertility problems.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery. However, dizziness and visual disturbances are adverse effects that may occur after taking NSAIDs. If these effects occur, do not drive or operate machinery.

Flurbiprofen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (3 sprays), i.e., essentially 'sodium-free'.

3. How to use FROBENGOLMED

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Always use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose for adults aged 18 years and over:
Administer 3 sprays (one dose) directed to the back of the throat every 3–6 hours as needed. Do not exceed 5 doses within 24 hours.
One dose (3 sprays) contains 8.75 mg of flurbiprofen.

Use in children and adolescents
Do not use this medicine in children or adolescents under 18 years of age.
For oromucosal use only.

• Spray only towards the back of the throat.
• Do not inhale during administration.
• Do not exceed 5 doses (15 sprays) in 24 hours.

FROBENGOLMED is intended only for short-term treatment.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If irritation of the mouth develops, treatment with flurbiprofen should be discontinued.
Do not use this medicine for more than 3 days unless otherwise prescribed by a doctor.
Consult your doctor or pharmacist if you do not notice improvement, if symptoms worsen, or if new symptoms develop.

Priming the pump
At first use (or after a prolonged period of non-use), the pump must be primed.
Point the nozzle away from your body and spray at least four times until a uniform and consistent mist is obtained. The pump is now primed and ready for use. If the product has not been used for a prolonged period, point the nozzle away from your body and spray at least once until a uniform and consistent mist is obtained.
Before each use, always ensure that the spray produces a uniform and consistent mist.

Using the spray pump

• Direct the nozzle towards the back of the throat.
• With a quick and firm motion, press the pump three times, ensuring complete depression with each spray. Remove your finger from the top of the pump between each spray.
• Do not inhale during administration.

If you use more FROBENGOLMED than you should
Contact your doctor, pharmacist, or go immediately to the nearest hospital. Symptoms of overdose may include: feeling unwell, nausea, stomach discomfort, or more rarely diarrhoea. Tinnitus, headache, and gastrointestinal bleeding are also possible.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking this medicine IMMEDIATELY and contact your doctor
if you develop any of the following conditions:

• severe forms of skin reaction, such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions caused by serious adverse reactions to the medicine or to an infection, in which a severe reaction involving the skin and mucous membranes occurs). Frequency: not known (frequency cannot be estimated from the available data);
• signs of anaphylactic shock characterised by swelling of the face, tongue or throat, leading to

difficulty breathing, rapid heartbeat, drop in blood pressure and subsequent shock (these reactions may also occur with the first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people);

• signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering rash, skin or mucosal desquamation or ulceration. Frequency: uncommon (may affect up to 1 in 100 people);
• signs of allergic reaction such as asthma, wheezing or unexplained shortness of breath, itching, runny nose or skin rash. Frequency: uncommon (may affect up to 1 in 100 people);

If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist:
Common (may affect up to 1 in 10 people):

• dizziness, headache
• sore throat
• mouth ulcers, mouth pain or numbness
• sore throat
• discomfort (sensation of heat, burning or tingling) in the mouth
• nausea and diarrhoea
• tingling and itching sensation of the skin

Uncommon (may affect up to 1 in 100 people):

• drowsiness
• blistering rash in mouth or throat, throat numbness
• abdominal swelling, abdominal pain, bloating, constipation, indigestion, feeling unwell
• dry mouth
• burning sensation in the mouth, altered taste sensation
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity of the throat

Not known (frequency cannot be estimated from the available data):

• anaemia, thrombocytopenia (low platelet count which may lead to bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure or heart attack
• hepatitis (inflammation of the liver)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FROBENGOLMED

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening, discard after 1 month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What FROBENGOLMED contains:
The active substance is flurbiprofen.
One dose (3 sprays) contains 8.75 mg of flurbiprofen, corresponding to 17.16 mg/ml of
flurbiprofen. One spray contains 2.92 mg of flurbiprofen. 1 ml of oral mucosa spray solution contains 17.16 mg of flurbiprofen.
The other components are sodium saccharin, citric acid, sodium hydroxide, disodium phosphate
dodecahydrate, betadex (E459), hydroxypropylbetadex, purified water, and cherry flavour (flavouring substances, flavouring preparations, natural flavouring substances, ethanol, water).

Description of the appearance of FROBENGOLMED and pack contents
The oral mucosa spray is a clear, colourless solution with a cherry taste.
FROBENGOLMED consists of a plastic bottle containing the solution equipped with a mechanical spray pump.
Each bottle contains 15 ml of solution, providing approximately 87 sprays.

Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(Netherlands)

Manufacturer
LABORATORIUM SANITATIS SL, C/ Leonardo Da Vinci, 11, Parque tecnologico de Alava, 01510,
Miñano, Álava, Spain.
Industria Quimica Y Farmaceutica Vir S.A. C/ De La Laguna 66 68 70 Poligono Industrial Urtinsa II
28923 Alcorcon, Madrid, Spain.